Identity
- Trade Name
- B&L(R) (AMEFOCON A) OXYGEN PERMEABLE LENS FDA PMA
- Generic Name
- Lens, contact (polymethylmethacrylate) FDA PMA
Identifiers
- PMA Number
- P830050 FDA PMA
- FDA Product Code
- HPX FDA PMA
Classification
- Device Class
- U FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S001 (THIRTY DAY TRACK) FDA PMA
This device is a contact lens made of polymethylmethacrylate, classified as an oxygen-permeable lens designed for ophthalmic use. It is intended for corneal or scleral fitting to correct refractive errors or provide therapeutic coverage, adhering to the nomenclature for contact lenses.
The B&L Oxygen Permeable Lens (Amefocon A) is supplied as a single-use or reusable product, depending on the specific prescription and clinical guidelines. It is regulated under an FDA Premarket Approval (PMA) with PMA number P830050 and product code HPX, with a supplement for labeling changes. Storage and handling must comply with sterile or clean conditions as dictated by clinical practice.
Frequently asked questions
What types of refractive errors or conditions can the B&L Oxygen Permeable Lens (Amefocon A) be prescribed for?
The B&L Oxygen Permeable Lens (Amefocon A) is designed for corneal or scleral fitting to correct refractive errors such as myopia, hyperopia, or astigmatism, as well as to provide therapeutic coverage for the cornea or sclera. Its polymethylmethacrylate material and oxygen-permeable properties make it suitable for extended wear under clinical guidance, though the specific prescription and use depend on individual patient needs and professional assessment.
Is the B&L Oxygen Permeable Lens (Amefocon A) single-use or reusable, and how should it be handled?
The B&L Oxygen Permeable Lens (Amefocon A) can be supplied as either single-use or reusable, determined by the prescription and clinical guidelines. If reusable, it must be cleaned, disinfected, and stored according to manufacturer instructions and sterile or clean handling protocols to prevent contamination. Always follow the prescribed care regimen to ensure safety and efficacy.
What regulatory pathway does the B&L Oxygen Permeable Lens (Amefocon A) follow, and what does this mean for clinicians?
The B&L Oxygen Permeable Lens (Amefocon A) is regulated under an FDA Premarket Approval (PMA) with PMA number P830050 and product code HPX. This means the device has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use. Clinicians should confirm the lens is prescribed and fitted according to the approved labeling and clinical guidelines to ensure compliance with regulatory requirements.
How should the B&L Oxygen Permeable Lens (Amefocon A) be stored, and what conditions are necessary?
Storage conditions for the B&L Oxygen Permeable Lens (Amefocon A) depend on whether it is single-use or reusable. Single-use lenses should be stored in a sterile, sealed packaging until use, while reusable lenses require clean or sterile handling after each use. Always adhere to clinical practice standards for storage to maintain integrity and prevent contamination, particularly if the lens is intended for extended wear.
What materials is the B&L Oxygen Permeable Lens (Amefocon A) made of, and why does this matter?
The B&L Oxygen Permeable Lens (Amefocon A) is made of polymethylmethacrylate (PMMA), a durable material designed for oxygen permeability to support corneal health during wear. This material choice helps reduce complications like hypoxia, making it suitable for both refractive correction and therapeutic applications. The oxygen-permeable property is particularly important for patients requiring extended or continuous wear.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P830050 | U | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA PMA P830050 23 fields · synced Sep 18, 2026